- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05238766
Behavioral Interventions to Increase Parent Adherence With Behavior Plans
February 26, 2025 updated by: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Contextual Behavioral Strategies to Help Parents Adhere to Behavior Plans for Children With Autism
Many children with autism demonstrate severe problem behavior (SPB) in the form of self-injury, aggression, and disruptive behavior.
Conducting a functional analysis and implementing derived treatments can produce effective behavior plans.
Nonetheless, skills training and an effective plan may not be sufficient to produce parent adherence.
This applied research proposal describes an approach to target the negative maintaining contingencies supporting parent reinforcement of problem behavior (accommodation) and nonadherence.
The intervention, borrowed from Acceptance and Commitment Therapy and Behavioral Activation strategies, is matched specifically to the hypothesized function of the problematic caregiver responses (negative reinforcement).
Parents who participate in the proposed investigation will be assigned to either the Defuse Experience Accept Live intervention (DEAL) protocol group or treatment as usual.
Five 45-min DEAL sessions will 1) introduce caregivers to behavior change strategies that maximize contact with positive-maintaining contingencies related to adherence, while undermining the contingencies that maintain accommodation, and 2) provide caregivers with new treatment-related committed actions that are sensitive to positive changes in parent-child interactions.
Within and between participant analyses will be conducted to determine the effectiveness of the DEAL protocol.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Kennedy Krieger Institute
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Columbia, Maryland, United States, 21046
- Kennedy Krieger Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Child under the age of 18 years,
- Child is diagnosed with ASD, as confirmed by the Gilliam Autism Rating Scale-3,
- Child problem behavior is socially-maintained as identified via functional analysis,
- Parent is English-speaking, and
- Parent attendance of at least 80% of appointments at entry into the study.
Exclusion Criteria:
- Child is older than 18 years of age,
- Child does not have ASD,
- Child's problem behavior is not socially-maintained,
- Parent does not speak English, and
- Parent attendance at time of study entry is less than 80%.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Treatment as Usual
This arm does not receive any intervention.
It will serve as a comparison for the experimental arm.
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Experimental: Treatment + DEAL
Parents in the Treatment plus Defuse Experience Accept Live (T+DEAL) arm will attend five 45-min DEAL sessions with a therapist.
Across the five sessions, the therapist will 1) introduce caregivers to behavior change strategies that maximize contact with positive-maintaining contingencies related to adherence, while undermining the contingencies that maintain accommodation, and 2) provide caregivers with new treatment-related committed actions that are sensitive to positive changes in parent-child interactions.
|
The DEAL protocol is an Acceptance and Commitment Therapy and Behavioral Activation informed clinical protocol to undermine accommodation and help parents adhere with behavioral treatment plan components.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accommodation to Adherence Change Score
Time Frame: Change from Time 1 (Week 1) to Time 2 (Week 7)
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Conditional probabilities derived from a contingency space analysis
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Change from Time 1 (Week 1) to Time 2 (Week 7)
|
|
Experiential Avoidance
Time Frame: Change from Time 1 (Week 1) to Time 2 (Week 7)
|
The Acceptance and Action Questionnaire 2nd Edition (AAQ-II) assesses experiential avoidance (EA).
The AAQ-II is a 7 item self-report instrument with a range of 7-49.
Higher scores are indicative of higher levels of experiential avoidance.
|
Change from Time 1 (Week 1) to Time 2 (Week 7)
|
|
Cognitive Fusion
Time Frame: Change from Time 1 (Week 1) to Time 2 (Week 7)
|
The Cognitive Fusion Questionnaire (CFQ) assesses cognitive fusion, or rigidly following self-generated rules.
The CFQ is a 7 item self-report instrument with a range of 7-49.
Higher scores are indicative of a higher level of cognitive fusion.
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Change from Time 1 (Week 1) to Time 2 (Week 7)
|
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Parenting Stress
Time Frame: Change from Time 1 (Week 1) to Time 2 (Week 7)
|
The Parenting Stress Index - Short Form (PSI-SF) is a 36 item self-report instrument that measures parenting stress on a 5-point Likert scale.
The Parental Distress subscale contains items that resemble statements that a parent might make about their own parenting skills.
Self-statements oftentimes may function as rules, which we conceptualize as a more specific measure of parent cognitive fusion.
Therefore, we consider high scores on this subscale to be reflective of parent-based cognitive fusion.
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Change from Time 1 (Week 1) to Time 2 (Week 7)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 21, 2022
Primary Completion (Actual)
November 4, 2024
Study Completion (Actual)
November 4, 2024
Study Registration Dates
First Submitted
January 19, 2022
First Submitted That Met QC Criteria
February 3, 2022
First Posted (Actual)
February 14, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 26, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00292589
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is not a plan at this time for individual participant data sharing outside of resultant published data.
The analytic plan for this trial includes within and between participant analyses.
These data may be available at some point in time by specific request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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